Commissioning and Qualification

vor 1 Woche

Visp, Schweiz Callista Group AG Vollzeit

Our partner is a global leader in life sciences that enables a healthier world by supporting companies in the pharmaceutical, biotechnology, and specialty ingredients markets. For our ongoing **Project in Switzerland**, we are seeking an experienced **Commissioning and Qualification (C&Q) Lead** to oversee critical C&Q activities related to utilities and equipment within the **Fill and Finish** area.

As the **C&Q Lead** for the Project, you will be responsible for planning, leading, and coordinating the commissioning and qualification (CQ) activities for a Liquid and Lyophilized vial filling line, including isolators and autoclaves. Reporting to the C&Q Manager, you will work closely with cross-functional teams, including Engineering, Operations, external vendors, and contractors, ensuring all CQ efforts are aligned with project timelines and regulatory standards.

**Key Responsibilities**:

- **Lead CQ Activities**:
Oversee the execution of CQ activities as per the **C&Q Plan** and associated Validation Plans, ensuring compliance with project and regulatory standards (cGMP).
- ** Commissioning Execution**:
Plan, schedule, and manage the execution of commissioning activities for designated systems and areas, focusing on Fill and Finish utilities and equipment.
- ** Coordination**:
Lead and coordinate the efforts of internal C&Q teams, Engineering, Operations, and external vendors/contractors to ensure smooth execution of CQ activities.
- ** Schedule Management**:
Develop and maintain the project’s C&Q schedule, aligning it with overall project timelines and incorporating input from various teams such as Automation, Electrical, Instrumentation, HSE, and Engineering.
- ** Documentation Support**:
Assist in updating the **Master C&Q Plan** and support plans during the lifecycle of the project. Contribute to the development of commissioning test plans, specifications, and documentation.
- ** Interdisciplinary Collaboration**:
Coordinate commissioning activities with Construction, Health, Safety & Environment (HSE), Automation, and other relevant teams to ensure seamless project integration.
- **Experience**:
Minimum 10 years of hands-on experience in **Commissioning and Qualification** for **Fill and Finish** systems, including Liquid and Lyophilized vial filling lines, isolators, and autoclaves.
- ** Education**:
Diploma or degree in **Mechanical** or **Chemical Engineering** preferred.
- ** Industry Expertise**:
Deep understanding of **cGMP** requirements and extensive field CQV execution experience.
- ** Technical Knowledge**:
Familiarity with **Kneat** software for documentation development and execution is an advantage but not mandatory.
- ** Language Skills**:
Proficiency in **English** (written and spoken) is required. **German** language skills are a plus.
- ** Soft Skills**:
Excellent interpersonal and communication skills, with the ability to work effectively in a cross-functional team and manage external partners and vendors.

You will be part of a dynamic and innovative team working on the cutting-edge of pharmaceutical manufacturing. This is a unique opportunity to contribute to a high-impact project in a collaborative and growth-oriented environment. If this role sparks your interest, do not hesitate to reach out.

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